Equivalence of Boosted Atazanavir Based Regimens and Currently Effective HAART Regimens
Status:
Completed
Trial end date:
2016-11-23
Target enrollment:
Participant gender:
Summary
The hypothesis for this study is whether a treatment regimen containing Atazanavir in
combination with Ritonavir will work as well as other regimens containing a protease
inhibitor and/or a Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) at controlling HIV
disease in children who are HIV+ and have high cholesterol or high triglycerides. . In this
study, children who have high cholesterol or high triglycerides as a result of their HIV
medicines, will have the PI or NNRTI in their medication regimen changed to Atazanavir, which
is a PI in combination with a low dose of Ritonavir (another PI). Atazanavir has been shown
in adults to result in lower cholesterol and triglycerides than other PI's and NNRTI's. The
dose of Atazanavir and Ritonavir will be according to the Package Insert for this drug that
is FDA approved for children. They will continue taking the other medications from the
pre-study regimen. Children will take study drug for 24 weeks, and will be able to continue
study drug after the study using commercially available drug. Lab tests and a physical exam
will be undertaken at 4 weeks, 12 weeks and 24 weeks after starting study drug to determine
how effective the new drug is and to monitor for possible side effects.